This invention relates to immunoregulators and their methods of use and preparation.
It is known to use synthetic adjuvants or immunoregulators. However, the selection of such regulators has been experimental and not based on sound theoretical principles because several factors necessary for such selection were not understood, such as: (1) the exact mechanism for the immune response; (2) if T-cells or B-cells or both T-cells and B-cells were involved; (3) the manner in which regulators interact with the immune system for a specific response; and (4) the manner in which compounds or mixtures can be synthesized to enable them to elicit the desired response.
A prior art synthetic adjuvant, dextran sulfate, has a polysaccharide molecule with anionic groups attached. The use of dextran sulfate as an adjuvant was disclosed in McCarthy, R. E., Arnold, L. W., and Babcock, G. F.: "Dextran Sulfate: An Adjuvant for Cell-Mediated Immune Responses, "Immunology, 32:964, 1977. The immune response was based upon trial and error and it was not known if it would stimulate a T-cell response without a B-cell response. It stimulated both T-cell response and B-cell response.
Thus, prior art techniques and adjuvants have had several disadvantages, such as: (1) they are not predictable except by trial and error; (2) new adjuvants cannot be easily discovered or synthesized; (3) it is difficult to know the best manner and time of using them; (4) they are not usable to elicit only certain responses such as to select one that stimulates a T-cell response but does not stimulate antibody synthesis; and (5) many of them are cytotoxic in effective dosages.